Predictive Factors for Resection and Survival in Type A Borderline Resectable Pancreatic Ductal Adenocarcinoma Patients After Neoadjuvant Therapy

Carcinoma, Pancreatic Ductal Clinical Trial

— PF-BARNA  

Official title:

Predictive Factors for Resection and Survival in Type A Borderline Resectable Pancreatic Ductal Adenocarcinoma Patients After Neoadjuvant Therapy: A Retrospective Cohort Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05489458
• Other study ID #: HUB-BR-PDAC-2022
• Status: Not yet recruiting
• Start date: September 2022
• Est. completion date: January 2023

Study information

• Verified date: August 2022
• Source: Hospital Universitari de Bellvitge
• Contact: Juli Busquets, MD, PhD
• Phone: 034932607623
• Email: jbusquets[@]bellvitgehospital.cat
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Radical surgical resection is the only curative treatment option for pancreatic cancer, but borderline resectable tumors have a high probability of incomplete exeresis. Although neoadjuvant therapy can improve the chances of complete exeresis, not all patients respond as expected.

Description:

Pancreatic cancer is an important cause of cancer-related death worldwide. Radical surgical resection still is the only curative treatment option today, but not all tumors are considered resectable. Among resectable tumors, some are deemed borderline and have a high probability of incomplete exeresis. Neoadjuvant therapy (NAT) can be a game-changer for borderline cases, and there is a lack of evidence on the predictive factors associated with resectability after neoadjuvant treatment. This study aims to assess the prognostic factors for resectability and survival after NAT in type A borderline resectable pancreatic ductal adenocarcinoma patients.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: January 2023
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients =18 years old.
• Both sexes.
• Diagnosed with a type A BR-PDAC between January 2010 and December 2019.
• Minimum follow-up period of 12 months.

Exclusion Criteria:

• Patients diagnosed with a type B or type C BR-PDAC.
• Patients diagnosed with a type A BR-PDAC who had disease progression prior to receiving NAT.

Related Conditions & MeSH terms

• Adenocarcinoma
• Carcinoma, Pancreatic Ductal

Intervention

Procedure:
• Resection
Type A BR-PDAC patients who had a favorable tumor/vascular structures relationship confirmed during surgical exploration underwent resection.
• No Resection
Type A BR-PDAC patients who did not have a favorable tumor/vascular structures relationship confirmed during surgical exploration did not undergo resection.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
BUSQUETS, JULI

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of type A BR-PDAC patients who, after receiving NAT (=3 cycles), undergo resection.	NAT was administered up to 6 cycles, and cycles were administered every 2 weeks.; The minimum time interval between the last NAT session and surgery was 4 weeks.	From 6 weeks until the end of the observation period (December 2019) or death (whichever occurs first)
Primary	The evolution of the plasmatic levels of CA 19-9 from starting NAT until the surgical exploration.	NAT was administered up to 6 cycles, and cycles were administered every 2 weeks.; The minimum time interval between the last NAT session and surgery was 4 weeks.	Up to 16 weeks
Primary	The evolution of the degree of vascular involvement in 64-MDCT scans from starting NAT until the surgical exploration.	We will evaluate the tumor's anatomical relationship with neighboring vascular structures before and after NAT, measured with 64-MDCT (multidetector computerized tomography) scans.; NAT was administered up to 6 cycles, and cycles were administered every 2 weeks.; The minimum time interval between the last NAT session and surgery was 4 weeks.	Up to 16 weeks
Primary	Overall survival	Time until death (from any cause)	From starting NAT until the end of the observation period (December 2019) or death (whichever occurs first).
Primary	The evolution of the plasmatic levels of CA 19-9		From starting NAT until end of the observation period (December 2019) or death (whichever occurs first).
Primary	The evolution of the degree of vascular involvement in 64-MDCT scans	The tumor's anatomical relationship with neighboring vascular structures; measured with 64-MDCT scans.	From starting NAT until end of the observation period (December 2019) or death (whichever occurs first).
Primary	Progression-Free Survival	Time until disease progression	From starting NAT until end of the observation period (December 2019) or disease progression (whichever occurs first).
Primary	The evolution of the plasmatic levels of CA 19-9		From starting NAT until end of the observation period (December 2019) or disease progression (whichever occurs first).
Primary	The evolution of the degree of vascular involvement in 64-MDCT scans	The tumor's anatomical relationship with neighboring vascular structures; measured with 64-MDCT scans.	From starting NAT until end of the observation period (December 2019) or disease progression (whichever occurs first).
Secondary	The number (percentage) of deaths at the end of the observation period.		From starting NAT until end of the observation period (December 2019)
Secondary	The number (percentage) of patients presenting disease progression at the end of the observation period.	Disease progression will be considered as the development of metastatic disease and/or an increase in the primary tumor size.	From starting NAT until end of the observation period (December 2019)
Secondary	The number (percentage) of patients presenting stable disease at the end of the observation period.	Stable disease will be considered as an insufficient increase or reduction in the primary tumor size or in its relationship with neighboring vascular structures (i.e., cases that cannot be classified as responders).	From starting NAT until end of the observation period (December 2019)
Secondary	The number (percentage) of patients considered responders at the end of the observation period.	Patients will be considered responders when the primary tumor presents a reduction in size and/or in its relationship with neighboring vascular structures.	From starting NAT until end of the observation period (December 2019)
Secondary	The number (percentage) of patients surgically explored at the end of the observation period.		From starting NAT until end of the observation period (December 2019)
Secondary	The Resection Rate at the end of the observation period.	The Resection Rate will be calculated by dividing the total number of resections performed by the total number of patients treated with NAT.	From starting NAT until end of the observation period (December 2019)